KR20200126980A - Catheter assembly with high viscosity lubricant and related method - Google Patents

Abstract

A method of preventing blood leakage through the septum of the catheter assembly when the needle is placed within the slit of the septum may include providing a lubricant within a plurality of gaps disposed between the slit and the outer surface of the needle. The lubricant may comprise a viscosity greater than 1,000 centipoise. Providing a lubricant within the plurality of gaps may include applying the lubricant to the outer surface of the needle, and inserting the lubricated needle distally through the slit of the septum. Providing lubricant within the plurality of gaps may include applying lubricant to a tip of a diaphragm actuator of a catheter assembly, and penetrating the diaphragm with a lubricated diaphragm actuator. Providing lubricant within the plurality of gaps may include dispensing lubricant within the slit of the septum prior to inserting the septum into the lumen of the catheter adapter.

Description

Catheter assembly with high viscosity lubricant and related method

Once the placement of the introducer needle in the patient's blood vessel is confirmed, the clinician can temporarily block the flow in the blood vessel and remove the introducer needle, leaving the catheter in place in the blood vessel. In some instances, the clinician may also attach the device to the catheter for fluid injection and/or blood withdrawal. This process is somewhat difficult in practice, as many catheter placement sites simply do not allow easy occlusion of blood vessels. Additionally, even if such occlusion is achieved, it may be incomplete, resulting in blood leakage from the catheter assembly containing the catheter, which may endanger the clinician.

Accordingly, in the art, a catheter assembly has been provided that provides various seals or “separates” to prevent leakage of fluid during and after removal of the introducer needle from the blood vessel. The septum may be secured within the catheter assembly through adhesive and/or friction between the septum and the wall of the catheter assembly.

However, if the needle is completely withdrawn from the septum, significant blood leakage through the septum can occur. Thus, in some instances, when the catheter is placed in the blood vessel, the clinician only partially withdraws the needle and inserts the needle into the slit of the septum in an attempt to avoid significant blood leakage that may occur when the needle is fully withdrawn. May be left-this may be referred to as "parking" the needle -. If the needle is parked or partially withdrawn and placed within the slit of the septum, there may still be some blood leakage through the slit of the septum, as the slit may not perfectly match the outer surface of the needle. Thus, in the art, there is a need for devices, systems and methods that prevent blood leakage through the slit in the septum when the needle is in the slit.

The present disclosure relates generally to a catheter assembly comprising a lubricant, as well as related devices and methods. In some embodiments, the lubricant can include a high viscosity lubricant, such as, for example, greater than 1,000 centipoise, which can facilitate blood control. In some embodiments, the lubricant can prevent blood from penetrating the septum of the catheter assembly when the needle of the catheter assembly is placed within the slit of the septum. More specifically, in some embodiments, the lubricant may be disposed within a number of gaps disposed between the outer surface of the needle and the slit of the septum, preventing blood leakage through the septum when the needle is placed within the slit of the septum. have.

In some embodiments, the catheter assembly may include a catheter adapter that may include a distal end, a proximal end, and a lumen extending between the distal and proximal ends. In some embodiments, the septum may be placed within the lumen of the catheter adapter. In some embodiments, the needle may be placed within the lumen of the catheter adapter. In some embodiments, the catheter assembly may include a catheter that can extend in a distal direction from a distal end of the catheter adapter. In some embodiments, the catheter assembly may include a septum actuator that may be configured to pierce the septum in response to inserting the medical device into the proximal end of the catheter adapter.

In some embodiments, a method of making a catheter assembly to prevent blood leakage through the septum when the needle is placed within the slit of the septum comprises providing a lubricant in the gap disposed between the outer surface of the needle and the slit of the septum. Can include. In some embodiments, providing lubricant within the gap disposed between the outer surface of the needle and the slit of the septum includes applying a lubricant to the outer surface of the needle and/or applying a lubricated needle prior to inserting the needle into the slit of the septum. It may include insertion in the distal direction through the slit of the septum. In some embodiments, in response to inserting a lubricated needle in a distal direction through a slit in the septum, a lubricant may be deposited within the gap. In some embodiments, in response to inserting the lubricated needle in the distal direction through the slit of the septum, at least a portion of the lubricant may be transferred from the needle to the gap due to contact between the slit and the lubricant on the needle.

In some embodiments, applying lubricant to the outer surface of the needle prior to inserting the needle into the slit of the septum may include applying lubricant to a portion of the outer surface of the needle. In some embodiments, a portion of the outer surface of the needle may be configured to be placed within the slit of the septum when the needle is in an insertion position for insertion into a patient. In some embodiments, the needle may extend beyond the distal end of the catheter when the needle is in the insertion position.

In some embodiments, providing lubricant in the gap disposed between the outer surface of the needle and the slit of the diaphragm is lubricating and/or lubricating the distal tip of the diaphragm actuator prior to inserting the diaphragm actuator into the slit of the diaphragm. Inserting the diaphragm actuator into the diaphragm may be included. In some embodiments, in response to inserting a lubricated diaphragm actuator into the diaphragm, a lubricant may be deposited within the slit. In some embodiments, in response to moving the diaphragm actuator through the slit, at least a portion of the lubricant may be transferred to the gap due to contact between the slit and lubricant on the diaphragm actuator.

In some embodiments, providing lubricant within the gap disposed between the outer surface of the needle and the slit of the septum may include dispensing the lubricant within the slit of the septum prior to inserting the septum into the lumen of the catheter adapter during manufacture.

In some embodiments, the slits of the diaphragm may include various shapes and sizes. In some embodiments, any number of gaps may be formed in response to a needle disposed within the slit. In some embodiments, the slit may be Y-shaped and include exactly three gaps. In some embodiments, the slit may be linear and may include exactly two gaps.

In some embodiments, the lubricant may include a water-insoluble lubricant. In some embodiments, the lubricant may include a gel lubricant. In some embodiments, the lubricant may comprise an oil lubricant, such as, for example, polydimethyl siloxane, polytrifluoropropylmethyl siloxane, or a copolymer of dimethylsiloxane and trifluoropropylmethylsiloxane. In some embodiments, the lubricant may include an antimicrobial agent and/or an anti-thrombogenic agent to reduce the likelihood of blood clots within the catheter assembly.

In some embodiments, a method of operating a catheter assembly may include inserting a needle of the catheter assembly into the patient's vascular system. In some embodiments, in response to inserting the needle into the patient's vascular system, a blood flashback may occur between the outer surface of the needle and the inner surface of the catheter. In some embodiments, lubricant disposed within the gap may prevent blood flashback from penetrating the septum when the needle is disposed within the slit of the septum.

In some embodiments, the catheter assembly may include a manual needle safety mechanism. In some embodiments, the method of operating the catheter may further include partially withdrawing the needle through a manual needle safety mechanism such that the distal tip of the needle is disposed between the distal end of the catheter and the septum. In these and other embodiments, the needle may extend through the septum when the needle is partially withdrawn, and the lubricant disposed within the gap prevents blood disposed on the outer surface of the distal tip of the needle from penetrating the septum. Can be prevented.

It is to be understood that the foregoing general description and the following detailed description are both illustrative and illustrative and do not limit the claimed invention.

Exemplary embodiments will be described and described with additional specificity and detail using the accompanying drawings.
1A is a longitudinal cross-sectional view of an exemplary catheter assembly with a needle removed in accordance with some embodiments;
1B is a longitudinal cross-sectional view of a catheter assembly illustrating an exemplary needle in an insertion position, in accordance with some embodiments;
2A is a cross-sectional view of the catheter assembly along line AA of FIG. 1A, in accordance with some embodiments;
2B is a cross-sectional view of the catheter assembly along line BB of FIG. 1B, in accordance with some embodiments;
3A is an alternative cross-sectional view of the catheter assembly along line AA of FIG. 1A, in accordance with some embodiments;
3B is an alternative cross-sectional view of the catheter assembly along line BB of FIG. 1B, in accordance with some embodiments;
4A is a longitudinal cross-sectional view of a needle with lubricant applied to the outer surface of the needle, in accordance with some embodiments;
4B is a longitudinal cross-sectional view of a catheter assembly during an exemplary manufacturing process, in accordance with some embodiments, illustrating a needle inserted into the proximal end of the exemplary catheter adapter and through the exemplary septum;
5A is a longitudinal cross-sectional view of a catheter assembly with an exemplary diaphragm actuator, in accordance with some embodiments;
5B is a longitudinal cross-sectional view of a diaphragm actuator inserted through a diaphragm, in accordance with some embodiments;
6A is a top perspective view of a catheter assembly with an exemplary needle shield mechanism, in accordance with some embodiments;
6B is a top perspective view of the catheter assembly with the needle shield mechanism removed from the catheter adapter;
6C is a longitudinal cross-sectional view of a catheter assembly, illustrating a partially withdrawn needle, in accordance with some embodiments.

The present disclosure relates generally to a catheter assembly comprising a lubricant, as well as related devices and methods. In some embodiments, the lubricant can include a high viscosity lubricant that can act as a blood barrier and facilitate blood control. In some embodiments, the lubricant can prevent blood from penetrating the septum of the catheter assembly when the introducer needle of the catheter assembly is placed within the slit of the septum. More specifically, in some embodiments, the lubricant may be disposed within a number of gaps disposed between the outer surface of the needle and the slit of the septum, preventing blood leakage through the septum when the needle is placed within the slit of the septum. have.

As used in this disclosure, the term "distal" refers to a catheter assembly or part of a component thereof that is further away from the user, and the term "proximal" refers to a catheter assembly or part of a component that is closer to the user. do. As used in this disclosure, the term “user” may refer to a clinician, physician, nurse, or any other medical personnel and may include support personnel.

Referring now to FIGS. 1A and 1B, the catheter assembly 10 may provide access to the patient's vascular system, for example for infusion therapy procedures or blood collection. In some embodiments, the catheter assembly 10 may include a catheter adapter 12 that may include a distal end, a proximal end, and a lumen 14 extending between the distal and proximal ends. In some embodiments, the catheter assembly 10 can include a catheter 16 that can include a peripheral intravenous catheter in fluid communication with the catheter adapter 12. In some embodiments, the catheter 16 may extend in a distal direction from the distal end of the catheter adapter 12.

In some embodiments, the catheter adapter 10 may include a blood control septum 18, which blood and other fluids between the proximal chamber 22 and the distal chamber 20 of the catheter adapter 12. It can act as a physical barrier to control the flow of. In some embodiments, septum 18 may be disposed within lumen 14 of catheter adapter 12. In some embodiments, in response to inserting the distal and/or beveled tip 24 of the introducer needle 26 and the distal tip 28 of the catheter 16 into the patient's vascular system and removing the needle 26, Blood from the patient may flow through the lumen 30 of the catheter 16 to the distal chamber 20. In these and other embodiments, blood will be prevented from bypassing the septum 18 due to the presence of lubricant 48 in the gap disposed between the outer surface of the needle 26 and the slit 46 of the septum 18. I can. Otherwise, the diaphragm 20 can substantially prevent blood from bypassing the diaphragm 18 when the needle 26 is placed in the slit 46 of the diaphragm 18, but some leakage occurs. It can pose a risk to the user.

1A illustrates the catheter assembly 10 prior to complete manufacture of the catheter assembly 10 such that the needle 26 is not yet inserted through the catheter adapter 12, according to some embodiments. In some embodiments, the needle may also be removed from the catheter adapter 12 after the catheter 16 has been placed within the patient's vascular system. 1B illustrates a catheter assembly 10 prepared for clinical use with a needle 18 placed in an insertion position for insertion into a patient, in accordance with some embodiments. In these and other embodiments, the tip 24 of the needle 26 may extend beyond the distal tip of the catheter 20. In some embodiments, needle 26 may be placed within lumen 14 of catheter adapter 12.

In some embodiments, catheter assembly 10 may include a needle hub (eg, illustrated in FIGS. 6A and 6B) capable of supporting needle 26. In some embodiments, the needle 26 is positioned through the catheter adapter 12 and the catheter 16 such that the tip 24 of the needle 26 extends beyond the distal tip 28 of the catheter 16. Can be. In some embodiments, tip 52 may provide a cut surface that penetrates the patient's skin and provides access to the vascular system.

In some embodiments, the septum 18 may be seated in an annular groove 34 provided in the inner surface 36 of the catheter adapter 12. In some embodiments, the diaphragm 18 may include an outer diameter that is greater than the diameter of the fluid path 32 and/or the diameter of the annular groove 34. Thus, the diaphragm 18 can be secured to the fluid path 32 and/or the annular groove 34, and is able to move within the fluid path 38 in the proximal direction 38 and/or the distal direction 40. Can be prevented. In some embodiments, the outer edge of the diaphragm 18 may be secured to the inner surface 36 through adhesive, plastic welding, retainer clips, or other mechanical connections.

In some embodiments, the diaphragm 18 may include a variety of shapes and configurations. For example, in some embodiments, the diaphragm 18 may comprise a disk. As another example, in some embodiments, the septum 18 may include a cylinder having a proximal opening 42. In some embodiments, the diaphragm 18 may include a slit 46 or multiple slits that may form a path through the diaphragm 18. In some embodiments, the distal end of the slit 46 may be disposed on the distal surface of the septum 18, the proximal end of the slit 46 may be disposed on the proximal surface of the septum 18, and the slit 46 The inner portion of the) may extend from the distal surface to the proximal surface through the inner surface of the septum 18. In some embodiments, the slit 46 may be configured to allow passage of the needle 26 through the septum 18. In some embodiments, the resilient or elastic properties of the septum 18 may allow the slit 26 to elongate to accommodate the passage of the needle 26.

In some embodiments, the slit 46 of the diaphragm 18 may include a variety of shapes and configurations. In some embodiments, any number of gaps may be formed in response to needle 26 disposed within slit 46. Referring now to Figures 2A and 2B, in some embodiments, the slit 46 may be linear, for example, and will include exactly two gaps when the needle 26 is placed within the slit 46. I can. Referring now to FIGS. 3A and 3B, in some embodiments, the slit 46 may be Y-shaped, for example, and includes exactly three gaps when the needle 26 is placed within the slit 46. can do. In some embodiments, the slit 46 may be X-shaped, for example, resulting in four gaps when the needle 26 is placed within the slit 46.

Referring collectively to FIGS. 2B and 3B, in some embodiments, lubricant 48 may be provided within the gap. In some embodiments, lubricant 48 may comprise a high viscosity lubricant. In some embodiments, the viscosity of the lubricant may be high enough to prevent blood from flowing through the gap in which the lubricant 48 is disposed. Thus, in some embodiments, the lubricant 48 may prevent blood from flowing from the distal chamber 20 through the gap to the proximal chamber 22 when the needle 26 is placed within the slit 46. have.

In some embodiments, the viscosity of lubricant 48 may be greater than 100 centipoise. In some embodiments, a viscosity of less than 100 centipoise may not be high enough to prevent blood from flowing through the gap in which the lubricant 48 is disposed. In a preferred embodiment, the viscosity of the lubricant 48 may be 1,000 centipoise or more, which may facilitate sealing of the gap and septum 18 when the needle 26 is placed within the slit 46. In some embodiments, the viscosity of the lubricant may be between 1,000 centipoise and 2,000,000 centipoise (including threshold). In some embodiments, lubricant 48 may include one or more of a gel, an oil, an antimicrobial agent, a fugitive solvent, an alcohol, and an antithrombotic agent, as described in further detail.

In some embodiments, the lubricant 48 may be insoluble in blood and/or in most infusions, so, for example, blood collection, drug infusion, total parenteral nutrition (TPN) procedures, and saline solution. And heparin can stay in the gap during many procedures such as perfusion.

In some embodiments, the lubricant 48 may comprise a viscous gel. In some embodiments, lubricant 48 may be shapeable. In some embodiments, lubricant 48 may include one or more oils. In some embodiments, the oil may include silicone, polydimethyl siloxane, polytrifluoropropylmethyl siloxane, a copolymer of dimethylsiloxane and trifluoropropylmethylsiloxane, or other suitable oil lubricant. In some embodiments, a solvent may be added to the oil lubricant to facilitate application of the lubricant 48.

In some embodiments, the lubricant 48 may include one or more antimicrobial agents, which may prevent colonization and growth of microorganisms and pathogens within the catheter assembly 10. In some embodiments, the antimicrobial agent may include solid particles that are insoluble in lubricant 48 or in liquid form. In some embodiments, the antimicrobial agent may be well mixed within the lubricant 48 prior to applying the lubricant 48 to the needle 26 and/or diaphragm actuator, as described in more detail.

In some embodiments, the lubricant 48 comprises one or more transient solvents, such as, for example, tetrahydrofuran (THF), methylethylketone (MEK), hexane solvent, or other suitable solvent. I can. In some embodiments, lubricant 48 may include an amount of temporary solvent approximately equal to 70% (w/v) of lubricant 48.

In other embodiments, lubricant 48 may include one or more alcohols. In some embodiments, lubricant 48 may comprise a lower alcohol having 1 to 6 carbons (C1-C6). In some embodiments, the alcohol component may include one or more of ethyl alcohol, isopropanol, propanol, and butanol. In some embodiments, lubricant 48 may include an alcohol component in an amount approximately equal to 40% (w/v) of lubricant 48. In other embodiments, lubricant 48 may include an alcohol component in an amount of about 20% (w/v) to about 95% (w/v).

In some embodiments, the lubricant 48 may include an antithrombotic agent. In some embodiments, antithrombotic agents can reduce the likelihood of blood clotting within the catheter assembly 10. In some embodiments, antithrombotic agents can reduce the likelihood of a blood clot on any surface coated by lubricant 48.

Referring now to FIGS. 4A and 4B, in some embodiments, lubricant 48 is applied to the outer surface of needle 26 prior to inserting needle 26 into slit 46 of septum 18. ) Can be applied to the gap. In some embodiments, lubricated needle 26 can be inserted through slit 46 to deposit lubricant 48 within the gap. In some embodiments, the lubricated needle 26 may be inserted in a distal direction through the slit 46 or in a proximal direction through the slit 46 as illustrated in FIG. 4B, for example.

In some embodiments, lubricant 48 may be applied to the outer surface of needle 26 by dipping, brushing, spraying, or any other suitable technique known in the art. In some embodiments, lubricant 48 may be applied to the outer surface of needle 26 prior to fully manufacturing catheter assembly 10 or prior to placing needle 26 within catheter assembly 10. In some embodiments, when inserting the needle 26 into the catheter adapter 12 and the slit 46 of the septum 18, the lubricant 48 may rub against the inner portion of the slit 46, thereby Thereby, the lubricant 48 can be deposited in the gap. In some embodiments, needle 26 may be inserted through septum 18 without providing an enlarged path through septum 18. For example, a threader cannot be used. In this way, the lubricant 48 can be displaced from the outer surface of the needle 26 during manufacture or assembly of the catheter assembly 10, according to some embodiments.

In some embodiments, lubricant 48 may be applied to one or more portions of the outer surface of needle 26. In some embodiments, lubricant 48 may be applied to the entire outer surface of needle 26. In some embodiments, lubricant 48 may be applied to tip 24 of needle 26. In some embodiments, the lubricant 48 is applied to a portion of the outer surface of the needle 26 configured to be placed within the slit 46 of the septum 18 when the needle 26 is in the insertion position for insertion into the patient. Can be applied. In some embodiments, lubricant 48 may be applied only to a portion of the outer surface of needle 26 configured to be disposed within slit 46 of septum 18 when needle 26 is in the insertion position, This can limit excess lubricant 48 within the catheter adapter 12.

In some embodiments, lubricant 48 disposed in the gap may prevent passage of fluid from distal chamber 20 to proximal chamber 22 when needle 26 is moved in proximal direction 38. . In some embodiments, completely removing the needle 26 from the slit 46 may cause the slit 46 to self-close, thereby preventing fluid in the distal chamber 20 from passing to the proximal chamber 22. can do.

In some embodiments, the catheter assembly 10 may be made such that the needle 26 is positioned in the insertion position and the lubricant 48 is coated on the distal side of the septum 18. In these and other embodiments, the lubricant 48 may be absent in the gap disposed between the outer surface of the needle 26 and the slit 46 of the septum 18. In some embodiments, prior to using the catheter assembly 10, the user may partially withdraw the needle 26 through the septum 18 to deposit lubricant within the gap.

Referring now to FIGS. 5A and 5B, in some embodiments, the catheter assembly 10 may include a septum actuator 50. In some embodiments, lubricant 48 may be applied to the outer surface of diaphragm actuator 50 by dipping, brushing, spraying, or any other suitable technique known in the art. In some embodiments, lubricant 48 may be applied to the outer surface of diaphragm actuator 50 prior to fully manufacturing catheter assembly 10 or prior to placing diaphragm actuator 50 within catheter assembly 10. In some embodiments, when inserting the diaphragm actuator 50 into the catheter adapter 12 and the slit 46 of the diaphragm 18, the lubricant 48 may rub against the inner portion of the slit 46, Thereby, the lubricant 48 can be deposited on the inner portion of the diaphragm 18. Thus, in some embodiments, when the needle 26 is inserted through the slit 46, the lubricant 48 may already be placed within the slit 46 and fill the gap.

In some embodiments, lubricant 48 may be applied to one or more portions of the outer surface of diaphragm actuator 50. In some embodiments, lubricant 48 may be applied to the entire exterior surface of diaphragm actuator 50. In some embodiments, lubricant 48 may be applied to tip 52 of diaphragm actuator 50. In some embodiments, the lubricant 48, when the diaphragm actuator 50 is moved in a distal direction in response to inserting another medical device 53 or assembly tool into the proximal end of the catheter adapter 12, the diaphragm ( 18) may be applied to a portion of the outer surface of the diaphragm actuator 50 configured to be disposed within the slit 46. In some embodiments, the tip 52 of the diaphragm actuator 50 may be placed abutting and proximal to the proximal surface of the diaphragm 18, or the diaphragm 18 when the medical device 52 is not in the catheter adapter 12. Can be spaced apart from the proximal surface of.

In some embodiments, prior to using the catheter assembly 10, the user may insert the diaphragm actuator 50 through the slit 46 to deposit lubricant within the gap. In these and other embodiments, the catheter assembly 10 may be manufactured without a lubricant disposed within the gap.

Referring now to FIGS. 6A-6C, in some embodiments, the catheter assembly 10 may include a needle shield or safety mechanism 54. Any suitable type of needle shielding mechanism 54 is contemplated. In some embodiments, the needle shielding mechanism 54 may be manual, which automatically retracts the needle 26 when it is withdrawn from the patient and at least a portion of the catheter adapter 12 in a proximal direction. It means any needle shielding mechanism 54 that shields. In some embodiments, for the manual needle shield mechanism 54, there is no user activation of the needle shield mechanism 54 other than proximal withdrawal of the needle 26 from at least a portion of the catheter adapter 12. For example, a button may be pressed, the catheter assembly 10 may be twisted or not clicked to activate the needle shield mechanism 54. In some embodiments, manual needle shielding mechanism 54 may engage during proximal withdrawal of needle 26 relative to catheter assembly 10. In some embodiments, the needle shielding mechanism 54 may be active, which attaches the needle 26 to at least a portion of the catheter adapter 12 to shield the distal tip of the needle 26 within the needle shield mechanism 54. It means that the user activates the needle shield mechanism 54 in a different way than or in addition to physically and proximal withdrawal from. For example, the active needle shielding mechanism 54 may involve pressing, twisting, or clicking a button. A non-limiting example of an active needle shielding mechanism 54 is included in a BD INSYTE AUTOGUARD™ BC shielded IV catheter. A non-limiting example of a manual needle shielding mechanism 54 is the BD NEXIVA™ closed IV catheter system.

In some embodiments, when the user partially withdraws the needle 26 from the catheter adapter 12 such that the tip 24 of the needle 26 is positioned between the distal end of the catheter 14 and the septum 18. , The lubricant 48 disposed in the gap may prevent blood disposed on the outer surface of the tip 24 from penetrating the diaphragm 18 through the slit 46. In some embodiments, the user may partially withdraw the needle 26 from the catheter adapter 12 such that the tip 24 of the needle 26 is positioned between the distal end of the catheter 14 and the septum 18. have. In these and other embodiments, the user may partially withdraw the needle 26 from the needle shield mechanism 54, which may be manual. In some embodiments, the exemplary manual needle shielding mechanism 54 may include a safety clip 56, which is in response to withdrawal of the needle 26 in a proximal direction from at least a portion of the catheter adapter 26. It can be removed from the catheter adapter 12 and the tip 24 is shielded within the safety clip 56.

6A and 6B also illustrate an exemplary needle hub 58, according to some embodiments. In some embodiments, when the needle 26 is partially withdrawn from the catheter adapter 12, the cross section of the catheter adapter 12, slit 46, and needle 26 is the same as or similar to FIG. 2B or 3B. can do. As illustrated in FIG. 6C, when the lubricant 48 is disposed within the gap, the lubricant 48 may also be disposed on another surface of the diaphragm 18 such as, for example, the distal or proximal surface.

Referring now to Figures 1-6, in some embodiments, the catheter assembly 10 to prevent blood leakage through the septum 18 when the needle 26 is placed within the slit 46 of the septum 18. An exemplary method of manufacturing) may include providing a lubricant 48 within a gap disposed between the outer surface of the needle 26 and the slit 46 of the septum. In some embodiments, providing the lubricant 48 within the gap disposed between the outer surface of the needle 26 and the slit of the diaphragm prior to inserting the needle 26 into the slit 46 of the septum 18 It may include applying lubricant 48 to the outer surface of 26) and/or inserting the lubricated needle 26 through the slit 46 of the septum 18 in a distal direction. In some embodiments, in response to inserting the lubricated needle 26 distally through the slit 46 of the septum 18, the lubricant 48 may be deposited within the gap. In some embodiments, in response to inserting the lubricated needle 26 in the distal direction through the slit 46 of the septum 18, at least a portion of the lubricant 48 is combined with the lubricant 48 on the needle 26. The contact between the slits 46 can be transferred from the needle 26 to the gap.

In some embodiments, applying the lubricant 48 to the outer surface of the needle 26 prior to inserting the needle 26 into the slit 46 of the septum 18 is a lubricant to a portion of the outer surface of the needle 26. (48) may include applying. In some embodiments, a portion of the outer surface of the needle 26 may be configured to be placed within the slit 46 of the septum 18 when the needle 26 is in an insertion position for insertion into a patient. In some embodiments, needle 26 may extend beyond the distal end of catheter 16 when needle 26 is in the insertion position.

In some embodiments, the catheter assembly 10 includes a septum actuator 50 that may be configured to penetrate the septum 18 in response to inserting the medical device 54 into the proximal end of the catheter adapter 12. I can. In some embodiments, providing the lubricant 48 within the gap disposed between the outer surface of the needle 26 and the slit 46 of the septum 18 brings the diaphragm actuator 50 to the slit 46 of the septum 18. ) Applying lubricant 48 to the distal tip 52 of the diaphragm 18 actuator and/or at least partially inserting the lubricated diaphragm actuator 50 into the diaphragm 18 prior to at least partially insertion into the diaphragm 18. Can include. In some embodiments, in response to inserting the lubricated diaphragm actuator 50 into the diaphragm, lubricant 48 may be deposited within the slit 46. In some embodiments, in response to moving the diaphragm actuator 50 at least partially through the slit 46, at least a portion of the lubricant 48 is between the lubricant 48 and the slit 46 on the diaphragm actuator 50. Can be transmitted to the gap due to the contact of.

In some embodiments, providing the lubricant 48 within the gap disposed between the outer surface of the needle 26 and the slit 46 of the septum 18 allows the diaphragm 18 to be inserted into the lumen 14 of the catheter adapter 12. It may include dispensing the lubricant 48 within the slit 46 of the septum 18 prior to insertion into ).

In some embodiments, a method of operating the catheter assembly 10 may include inserting the needle 26 of the catheter assembly 10 into the patient's vascular system. In some embodiments, in response to inserting the needle 26 into the patient's vascular system, a blood flashback may occur between the outer surface of the needle 26 and the inner surface of the catheter 16. In some embodiments, a notch in the needle 26 disposed within the catheter 16 may enable blood flashback. In some embodiments, the lubricant 48 disposed within the gap may prevent blood flashback from penetrating the septum 18 when the needle 26 is disposed within the slit 46 of the septum 18.

In some embodiments, the method of operating the catheter is to partially position the needle 26 against the catheter adapter 12 such that the tip 24 of the needle 26 is positioned between the distal end of the catheter 16 and the septum 18. It may further include to withdraw. In these and other embodiments, the needle 26 may be moved proximally and partially through a needle shielding mechanism 54, which may be passive. In some embodiments, the needle 26 may not be partially withdrawn relative to the catheter adapter 12 when the catheter system 10 includes an active needle shield mechanism 54, which is a risk of needle exposure. Because it can be raised. In these and other embodiments, the needle 26 may extend through the septum 18 when the needle 26 is partially withdrawn, and the lubricant 48 disposed within the gap is applied to the tip of the needle 26. It is possible to prevent blood disposed on the outer surface of 24 from penetrating the septum 18.

The invention may be embodied in other specific forms without departing from its structure, method, or other essential features, as broadly described herein and claimed below. The described embodiments and examples are to be considered as examples only and not limitation in all respects. While the implementation of the present invention has been described in detail, it should be understood that various changes, substitutions, and alterations may be made to the present invention without departing from the spirit and scope of the present invention.

Claims (20)

A method of manufacturing a catheter assembly for preventing blood leakage through the septum of the catheter assembly when the needle is placed within the slit of the septum, the step of providing a lubricant in a plurality of gaps disposed between the outer surface of the needle and the slit of the septum. Containing, method. The method of claim 1, wherein the lubricant is a high viscosity lubricant having a viscosity greater than 1,000 centipoise. 2.
Applying a lubricant to the outer surface of the needle prior to inserting the needle into the slit of the septum; And
A method comprising the step of inserting a lubricated needle through the slit of the septum in a distal direction, and in response to inserting the lubricated needle through the slit of the diaphragm in the distal direction, the lubricant is deposited within the plurality of gaps. The method of claim 3, wherein applying the lubricant to the outer surface of the needle prior to inserting the needle into the slit of the septum comprises applying a lubricant to a portion of the outer surface of the needle, wherein a portion of the outer surface of the needle, Wherein the needle is configured to be placed within the slit of the septum when in the insertion position for insertion into the patient. The method of claim 1, wherein the catheter assembly:
A catheter adapter having a distal end, a proximal end, and a lumen extending between the distal and proximal ends;
A catheter extending in a distal direction from the distal end of the catheter adapter;
A septum disposed within the lumen of the catheter adapter and having a slit; And
A septum actuator configured to penetrate the septum in response to insertion of the medical device into the proximal end of the catheter adapter,
Providing lubricant in a plurality of gaps disposed between the outer surface of the needle and the slit of the septum comprises:
Applying lubricant to the distal tip of the diaphragm actuator prior to inserting the diaphragm actuator into the slit of the diaphragm; And
Inserting the lubricated diaphragm actuator into the diaphragm, and in response to insertion of the lubricated diaphragm actuator into the diaphragm, the lubricant is deposited within the slit. The method of claim 5, wherein providing lubricant in the plurality of gaps disposed between the outer surface of the needle and the slit of the diaphragm comprises inserting the lubricated diaphragm actuator into the diaphragm and then inserting the needle into the proximal end of the catheter adapter, and The method further comprising the step of inserting through. The method of claim 1, wherein providing the lubricant in the plurality of gaps disposed between the outer surface of the needle and the slit of the septum comprises dispensing the lubricant within the slit of the septum prior to insertion of the septum into the lumen of the catheter adapter. How to. The method of claim 1, wherein the slit is a Y-shaped slit and the plurality of gaps comprises exactly three gaps. The method of claim 1, wherein the slit is a linear slit, and the plurality of gaps comprises exactly two gaps. The method of claim 1, wherein the lubricant comprises a water-insoluble lubricant. The method of claim 1, wherein the lubricant comprises an oil lubricant such as polydimethyl siloxane, polytrifluoropropylmethyl siloxane, or a copolymer of dimethylsiloxane and trifluoropropylmethylsiloxane. How to operate the catheter assembly,
Inserting the needle of the catheter assembly into the patient's vascular system, the catheter assembly comprising:
A catheter adapter having a distal end, a proximal end, and a lumen extending between the distal and proximal ends;
A catheter extending in a distal direction from the distal end of the catheter adapter;
A septum disposed within the lumen of the catheter adapter and having a slit;
A needle extending through the catheter, wherein the needle is in an insertion position for insertion into a patient, and the distal tip of the needle is disposed at the distal side of the distal end of the catheter when the needle is in the insertion position; And
A method comprising a lubricant disposed within a plurality of gaps disposed between the outer surface of the needle and the slit of the septum. The method of claim 12, wherein in response to the insertion of the needle into the patient's vascular system, a blood flashback occurs between the outer surface of the needle and the inner surface of the catheter, and the lubricant disposed within the plurality of gaps comprises the needle within the slit of the septum When deployed, a method of preventing blood flashback from penetrating the septum. The method of claim 12, wherein the catheter assembly further comprises a manual needle safety mechanism, the method comprising partially withdrawing the needle through the manual needle safety mechanism such that the distal tip of the needle is disposed between the distal end of the catheter and the septum. The method further comprising: the needle extending through the septum when the needle is partially withdrawn, and the lubricant disposed within the plurality of gaps prevents blood disposed on the outer surface of the distal tip of the needle from penetrating the septum. The method of claim 12, wherein the lubricant is a high viscosity lubricant having a viscosity greater than 1,000 centipoise. The method of claim 12, wherein the lubricant comprises a water-insoluble lubricant. Is a catheter assembly,
A catheter adapter having a distal end, a proximal end, and a lumen extending between the distal and proximal ends;
A catheter extending in a distal direction from the distal end of the catheter adapter;
A septum disposed within the lumen of the catheter adapter and having a slit;
A needle extending through the catheter and septum, wherein the distal tip of the needle is disposed at the distal side of the distal end of the catheter when the needle is in the insertion position; And
A lubricant disposed in a plurality of gaps disposed between the outer surface of the needle and the slit of the diaphragm, which is a high viscosity lubricant having a viscosity greater than 1,000 centipoise.
Containing, catheter assembly. The catheter adapter of claim 17, further comprising a manual needle safety mechanism coupled to the catheter adapter, wherein the manual needle safety mechanism is positioned on the catheter adapter such that the distal tip of the needle is disposed proximal to the distal end of the catheter and distal to the septum. The catheter assembly, which allows partial withdrawal of the needle in a direction proximal to the relative, and the lubricant prevents blood leakage through the slit of the septum when the needle is partially withdrawn. Is a catheter assembly,
A catheter adapter having a distal end, a proximal end, and a lumen extending between the distal and proximal ends;
A catheter extending in a distal direction from the distal end of the catheter adapter;
A septum disposed within the lumen of the catheter adapter and having a slit;
A catheter and a needle extending through the septum, wherein the distal tip of the needle is disposed on the distal side of the distal end of the catheter, the outer surface of the needle includes a lubricant on the distal side of the septum, and the lubricant is less than 1,000 centipoise. A high viscosity lubricant having a high viscosity, wherein the lubricant is not present in a plurality of gaps disposed between the outer surface of the needle and the slit of the septum. The catheter adapter of claim 19, further comprising a manual needle safety mechanism coupled to the catheter adapter, wherein the manual needle safety mechanism is attached to the catheter adapter such that the distal tip of the needle is disposed proximal to the distal end of the catheter and distal to the septum. The catheter assembly, which allows partial withdrawal of the needle in a direction proximal to the relative, and a lubricant is applied to the plurality of gaps in response to the partial withdrawal of the needle.

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